Alphatec Holdings (Alphatec) has received the CE Mark for commercial sale in the EU and other jurisdictions for its OsseoScrew Spinal Fixation System and its Guided Lumbar Interbody Fusion (GLIF) System / Arc Portal System.
The company said that the receipt of the CE Mark allows Alphatec Spine to begin selling these implants in the EU and certain other jurisdictions that recognise the CE Mark for commercial approval.
The OsseoScrew Spinal Fixation System is an innovative concept in pedicle screw fixation. The OsseoScrew provides three points of fixation; the pedicle, the transverse/superior facet, and the junction of the anterior pedicle and vertebral body.
The OsseoScrew implant is an expandable pedicle screw that addresses the challenges of demanding spinal fusion constructs in which there is a need for fixation with clinically proven technology that enhances the fixation in the bone-implant interface by 30%.
The OsseoScrew system is scheduled for its first European clinical use in February 2010. The OsseoScrew system is not available for sale in the U.S. and the Company is in discussions with the FDA to obtain 510(k) clearance for the product.
The Guided Lumbar Interbody Fusion (GLIF) technique and ARC Portal Access System is designed to provide surgeons with trans-psoas access and direct visualization to the intervertebral disc space while allowing the patient to remain in a prone position during lumbar interbody fusion procedures.
Furthermore, the GLIF system is designed to reduce intra-operative blood loss and minimise tissue disruption while decreasing the post-operative recovery time for most patients. When augmented with posterior pedicle fixation, the GLIF system eliminates the need to reposition the patient intra-operatively, thereby reducing the overall length of the lateral lumbar fusion procedure and potentially reducing operating room costs.
The company expects to begin a limited market release of the GLIF system in Europe during the second half of 2010.
Dirk Kuyper, president and CEO of Alphatec, said: “We are pleased to announce that the second product from our Aging Spine development pipeline is available for commercial release in the EU. The OsseoScrew Spinal Fixation System is the only available option for patients that adequately addresses the challenging spinal fusion constructs that need an increased level of fixation.
“The OsseoScrew has an expandable region that locks the screw into the neck of the pedicle, in a manner that is similar to how a molly bolt is used in dry wall. Our biomechanical testing has confirmed that the expanded screw provides a 30% improvement of the bone/implant interface as compared to a standard pedicle screw.”